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CLIA or FDA approval? – US Regulatory strategies for commercializing biomarker based tests

Current landscape of medical diagnostics,  public considerations and significance From a scientific perspective, this may be a “Golden Age” of diagnostics. The development of methods for identifying and quantifying minute amounts of biomarkers, and new computational techniques that allow the development of algorithms that define relationships between biomarkers and clinical conditions have combined to stimulate…Continue Reading…

Patent protection, trade secrets &/or open innovation in the successful path towards personalization of medicine

Traditionally, medicine relied on information such as family history, environment, behaviors and simple tests to tailor health care to patients. New discoveries are now enabling a unique and deeper understanding of individuals on a molecular level which are increasingly being translated into inventions with the potential to prevent, manage and cure a larger number of…Continue Reading…

Biomarker discovery & validation: Shifting research away from silos & towards collaborative endeavours

A fundamental challenge in developing drugs for certain diseases is that there is relatively little known about the pathophysiology or the natural history of the disease. Moreover, there are only a small number of experienced clinical investigators worldwide and little scientific literature published. The consequence of this is that there is uncertainty about the disease…Continue Reading…